Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2023

Month: January

Request Number: A-2020-000178

Request Summary: The patient consent forms, clinical trial protocols, and investigator brochures/information (including amendments to any of the foregoing) for the following clinical trials included in: 1. Title: Multicenter Study of the Safety and Efficacy of the Human Anti-Tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis. 2. Title: Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy. 3. Title: Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis. 4. Title: A Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn’s Disease. 5. Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn’s Disease, Open Label Extension.

Disposition: Disclosed in part

Number of pages: 1500

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